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New treatment option for Sepsis
Official title Vancomycin and Acute Kidney Injury in Sepsis Treatment - Intervention
ClinicalTrials.gov ID: NCT07084129
What this study is testing
- What it's testing
- The goal of this clinical trial is to determine if vancomycin dosing in children with sepsis can be improved by using updated, personalized dosing models that account for new markers of an individual's kidney function. Vancomycin is prescribed based on the known information of how the body breaks this medicine down.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- Age \>1 month and \<18 years
- Weight \>5kg and \<50kg
- Vancomycin intended duration of therapy ≥48 hours
- Admitted to intensive care unit with suspected or confirmed sepsis
- Either sepsis-induced respiratory (invasive mechanical ventilation) or cardiovascular (vasoactive infusion) dysfunction as part of sepsis-associated...
You likely can't join if
- Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy
- Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)\>1
- Central nervous system infection
- Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy)
- Pregnancy
- Patients on chronic dialysis therapy
See the full eligibility criteria
- Age \>1 month and \<18 years
- Weight \>5kg and \<50kg
- Vancomycin intended duration of therapy ≥48 hours
- Admitted to intensive care unit with suspected or confirmed sepsis
- Either sepsis-induced respiratory (invasive mechanical ventilation) or cardiovascular (vasoactive infusion) dysfunction as part of sepsis-associated organ dysfunction (these organ dysfunctions may be improving or...
- Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy
- Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)\>1
- Central nervous system infection
- Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy)
- Pregnancy
- Patients on chronic dialysis therapy
- Patients with known history of delayed vancomycin clearance based on local pharmacy records
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.